Dong-A ST Completes European Approval Application for 'Stelara' Biosimilar

Dong-A ST announced on the 14th that it has completed the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ‘DMB-3115,’ a biosimilar (biopharmaceutical generic) under development based on Stelara (active ingredient ustekinumab).

Exterior view of Dong-A ST headquarters building
[Photo by Dong-A ST]

Intas, an Indian multinational pharmaceutical company that signed a global license-out agreement for DMB-3115 with Dong-A ST and Meiji Seika Pharma, announced that the MAA submitted to the EMA last month through its subsidiary Accord Healthcare was accepted on the 13th (local time), completing the application process.

This MAA for DMB-3115 was based on the demonstration of quality equivalence with the original product conducted in the US and Europe. The global Phase 3 clinical trial targeted patients with moderate to severe chronic plaque psoriasis. The primary efficacy endpoint was set as the percentage change from baseline in the Psoriasis Area and Severity Index (PASI). As a result, DMB-3115 demonstrated therapeutic equivalence to Stelara, and no significant differences in safety were observed.

Stelara is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen (a Johnson & Johnson subsidiary). It is a blockbuster product used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The substance patent for Stelara is expected to expire in September in the US and in July 2024 in Europe. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.77 billion (approximately 22.5463 trillion KRW) last year.

Accordingly, Dong-A Socio Holdings and Meiji Seika Pharma have been jointly developing DMB-3115 since 2013. In 2020, to efficiently carry out the global project, the development and commercialization rights holder on Dong-A’s side was changed to Dong-A ST, and joint development with Meiji Seika Pharma has continued.

In July 2021, a global license-out agreement for DMB-3115 was signed with Intas. Accordingly, exclusive rights for approval and sales in global regions excluding some Asian countries such as Korea and Japan were transferred to Intas. Intas plans to commercialize DMB-3115 worldwide through its affiliates, including Accord Biopharma in the US and Accord Healthcare in Europe, the UK, and Canada. Dong-A ST and Meiji Seika Pharma will be responsible for research and development of DMB-3115 and exclusively supplying the product to Intas, Accord Biopharma, and Accord Healthcare.

Paul Tredwell, Senior Vice President of Accord Healthcare, said, “Accord Healthcare has completed the regulatory submission for the drug through a strong partnership with Dong-A ST and Meiji Seika Pharma. We are pleased to strengthen our commitment to improving access to high-quality biosimilars for patients worldwide.”

Jae-Hong Park, Head of R&D at Dong-A ST, said, “Dong-A ST will further strengthen cooperation with Meiji Seika Pharma, Intas, and Accord to ensure that high-quality DMB-3115 can be supplied to the global market.”

This content was produced with the assistance of AI translation services.